Treatment for adults with acute relapses or flares of multiple sclerosis (MS). Studies have shown H.P. Acthar Gel to be effective in speeding recovery from an MS relapse. However, there is no evidence that Acthar affects the ultimate outcome or natural history of the disease.

Acthar is injected beneath the skin or into the muscle.

IMPORTANT SAFETY INFORMATION

DO NOT take Acthar until you have talked to your doctor if you have any of the following conditions:

A skin condition called scleroderma

Bone density loss or osteoporosis

Any infections, including fungal, bacterial, or viral

Eye infections, such as ocular herpes simplex

Had recent surgery

Stomach ulcers or a history of ulcers

Heart failure

Uncontrolled high blood pressure

Allergies to pig-derived proteins

Have been given or are about to receive a live or live attenuated vaccine

Suspected congenital infections (in children under 2 years of age)

If you have been told that you have Cushing’s syndrome or Addison’s disease

Tell your doctor about any other health problems that you have. Give your doctor a complete list of medicines you are taking. Include all nonprescription medicines, vitamins, and herbal supplements that you are taking.

What is the most important information I should know about Acthar?

Never inject Acthar directly into a vein

Always inject Acthar beneath the skin or into the muscle

Follow your doctor’s instructions for injecting Acthar

Never stop treatment suddenly unless your doctor tells you to do so

Try not to miss any scheduled doctor’s appointments. It is important for the doctor to monitor you while taking Acthar

Acthar and corticosteroids have similar side effects.

You may be more likely to get new infections. Also, old infections may become active. Tell your doctor if you see any signs of an infection. Contact your doctor at the first sign of an infection or fever. Signs of infection are fever, cough, vomiting, or diarrhea. Other signs may be flu or any open cuts or sores

When taking Acthar long term, your adrenal gland may produce too much of a hormone called cortisol. This can result in symptoms of Cushing’s syndrome. This may cause increased upper body fat, a rounded “moon” face, bruising easily, or muscle weakness

Sometimes when you stop taking Acthar long term, your body may not produce enough natural cortisol. This is called “adrenal insufficiency.” Your doctor may prescribe a steroid medicine to protect you until the adrenal gland recovers

You might develop high blood pressure, or retain too much fluid. As a result of this, your doctor may recommend some changes to your diet, such as eating less salt and taking certain supplements

Vaccines may not work well when you are on Acthar. Talk to your doctor about which vaccines are safe to use when you are taking Acthar

Acthar may hide symptoms of other diseases. This can make it more difficult for your doctor to make a diagnosis if something else is going on

Long-term Acthar use can affect growth and physical development in children This can be reversed when Acthar is no longer needed

Acthar may cause osteoporosis (weak bones)

Acthar might harm an unborn baby. Therefore, tell your doctor if you are pregnant or plan on becoming pregnant

What are the most common side effects of Acthar?

The most common side effects of Acthar are similar to those of steroids. They include:

Fluid retention

High blood sugar

High blood pressure

Behavior and mood changes

Changes in appetite and weight

Specific side effects in children under 2 years of age include:

Increased risk of infections

High blood pressure

Irritability

Symptoms of Cushing’s syndrome

Thickening of the heart muscle (cardiac hypertrophy)

Weight gain

The above side effects may also be seen in adults and children over 2 years of age.

These are not all of the possible side effects of Acthar.

Tell your doctor about any side effect that bothers you, or that does not go away. Call your doctor or pharmacist for medical advice about side effects. You may report side effects to the FDA. Call 1-800-FDA-1088 or visit www.fda.gov/medwatch. You may also report side effects by calling 1-800-778-7898.